WASHINGTON — The Food and Drug Administration on Tuesday issued guidance indicating that the agency would give pharmacies until Nov. 1, 2015 — an additional four months — to comply with product tracing requirements scheduled to take effect July 1, 2015.
The FDA will not take enforcement action against a pharmacy that receives any drug product without also receiving the tracing information until Nov. 1, 2015. However, as of July 1, pharmacies are responsible for transmitting tracing documentation to purchasers of their drugs, when required to do so under the DSCSA. Starting Nov. 1, 2015, pharmacies will have to comply with the full scope of the DSCSA dispenser tracing requirements.
Commenting on the news, National Community Pharmacists Association CEO B. Douglas Hoey issued a statement that read: “Pharmacists appreciate and support the FDA’s decision announced today, which will help protect patients from disruptions in access to prescription drugs that may have otherwise and inadvertently occurred. Due to circumstances beyond their control, many pharmacies would have had difficulty complying with the July 1 statutory deadline. The FDA’s latitude should hopefully allow pharmacies to continue to work with their wholesaler partners in order to achieve compliance with new product tracing requirements intended to enhance the safety of the U.S. pharmaceutical system.”
On Nov. 27, 2013, the President signed the Drug Supply Chain Security Act into law, which helps ensure that the drug supply chain is secure from the point of manufacture through to the point at which pharmacies dispense those drugs to their patients. Implementation of the law has been ongoing over the past year and half. Starting July 1, 2015, pharmacies were to be required to only accept drugs that were shipped with corresponding tracing documentation.
While National Association of Chain Drug Store members worked hard to achieve DSCSA compliance by July 1, NACDS stated that it requested enforcement discretion from the FDA on two drug product categories — 340B drugs and drop shipment drugs — to help ensure that patients were not delayed in receiving their much-needed medications.
Because of the structure of the 340B program, in many instances a wholesaler will send the 340B drug to the pharmacy and send the tracing documentation to the health care entity. This undermines the intent of the DSCSA to require both the drug product and the tracing documentation to flow together through the supply chain, NACDS stated.
While the manufacturers of drop shipment drugs are able to send the tracing data directly to the pharmacies, progress has been slow in developing an electronic method for transmitting that tracing data, NACDS stated. Electronic transmission is critical for pharmacies because the DSCSA requires pharmacies to have such data readily available in case the FDA needs to investigate possibly illegitimate drug products.